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Genentech has reported the P-III (MAJESTY) trial results assessing Gazyva vs tacrolimus in 142 pts with primary membranous nephropathy
Trial met its 1EP, showing higher CR at Wk. 104 & achieved its key 2EPs, incl. improved overall remission & CR at Wks. 104 & 76, respectively; data to be presented in the future &…
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Genentech has reported the P-III (FENtrepid) trial data assessing fenebrutinib (QD, PO) with IV Ocrevus-matching PBO vs Ocrevus & oral fenebrutinib-matching PBO in 985 adults with PPMS
Trial met its 1EP, showing a 12% reduction in disability progression (cCDP12) with curves separating by wk. 24 & consistent benefit across subgroups & duration. The strongest effect was…
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SanegeneBio has entered into a global licensing agreement with Genentech (Roche) to advance one of its RNAi programs, using SanegeneBio's RNAi platform
As per the deal, Genentech will receive exclusive worldwide rights to develop & commercialize the program, with SanegeneBio handling early development activities, after which Genentech will lead subsequent development & commercialization efforts …
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Roche has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer
At the interim analysis, trial met its 1EP of improved invasive disease-free survival (iDFS) by 30%, with 92.4% vs 89.6% pts alive & invasive disease free…
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Genentech has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer
Trial met its 1EP of improved invasive disease-free survival & showed a favorable OS trend; OS data remains immature. Results to be presented in future meetings…
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Genentech has reported the P-III trials results, incl. FENhance 2 study assessing fenebrutinib (PO) vs teriflunomide in 1,497 adults with RMS for ~96wks.
Trial met its 1EP of reduced annualized relapse rate over ~96wks. with favorable liver safety; additional safety data will be further evaluated; data to be presented in future meeting, along with…
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Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300Â adults with SLE on SoC for 52wks. followed by ~104wks. OLE period
Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…
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Ventus Therapeutics has entered a multi-year collaboration with Genentech to discover and optimize novel small-molecule drugs for major diseases using its ReSOLVE platform
As per the deal, Ventus will utilize its ReSOLVE platform to identify small-molecule leads for multiple targets, while Genentech will be responsible for preclinical, clinical, and commercial development. Ventus will receive…
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The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible pts
Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…
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Starpharma has entered into a collaboration & license agreement with Genentech to develop dendrimer-drug conjugates incorporating Genentech’s drugs for oncology targets, leveraging Starpharma’s DEP drug delivery tech
As per the deal, Genentech will receive an exclusive global license under Starpharma’s IP to develop & commercialize collaboration-derived products, potentially multiple per target, in exchange for…

